ELUTIA INC. Q4 FY2025 earnings call

• Mission: Humanizing medicine so patients can thrive without compromise, focusing on breast cancer and related issues.
• Product highlights: LU Pro launched in January last year with a $18 million run rate. Announcement of new board member Guido Nils and Chief Commercial Officer Pete Ligotti. Submission of NXT 41 to FDA, expecting clearance in second half of the year with NXT 41X clearance expected towards end of first half of 2027. Manufacturing focused on ensuring quality tissue supply and reducing cost of goods. SimpliDerm is a great product with strategic options being explored. Company certified by Great Place to Work, with 54% women, 62% leadership roles by women, 50% advanced degrees, average tenure 6.3 years, outperforming peers on financial metrics, attracting job seekers better, and lower turnover.

For the fourth quarter, revenue was $3.3 million, up 16% from the year - ago quarter of $2.8 million. Adjusted gross margin for the fourth quarter was 66.8%, up from 56.5% in the prior year quarter. Net loss from continuing operations was $6.5 million vs. $7.2 million a year ago. Adjusted EBITDA was a loss of $4.2 million in the quarter compared to $3.4 million in the year - ago quarter. Cash on hand plus escrow was $44.4 million after paying off debt. Share count was 42.8 million common shares outstanding with 4.5 million pre - funded warrants. SimpliDerm is being explored for strategic options.

• Expect clearance for NXT 41 in second half of 2026.
• Expect clearance for NXT 41X towards end of first half of 2027.
• Focused on continued development and launch of NXT 41, well - resourced with strong balance sheet.

Q: Congrats on the progress and 41 submission to the FDA, asked about FDA questions and shifting from 41 to 41X.

A: View review process with respect, timelines are conservative, submit high - quality application, prepared for biocompatibility questions, will learn from 41 submission and go efficiently to 41X.

Q: Asked about balancing Simpliderm readiness and strategic transition, and commercial readiness.

A: Understand market, reimbursement, learned from LU Pro's VACs process, have strong KOL engagement.

Q: Asked about how NXT 41X compares to other infection reduction techniques.

A: Has advantages like uniform distribution and longer - term antibiotic coverage compared to plates and beads which have issues with non - uniform coverage and fast antibiotic elution, but some cases with severe necrosis are still challenging